Vaccine Therapy in Treating Patients With Recurrent Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00005628|
Recruitment Status : Completed
First Posted : April 2, 2004
Last Update Posted : June 19, 2013
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent soft tissue sarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Biological: vitespen||Phase 2|
OBJECTIVES: I. Determine the efficacy of autologous tumor cell-derived heat shock protein peptide vaccine in terms of the rate of complete and partial response and time to progression in patients with recurrent soft tissue sarcoma. II. Determine the safety and tolerability of this treatment regimen in this patient population. III. Determine the anti-tumor response to this treatment regimen in these patients.
OUTLINE: At approximately 5 weeks after surgery, patients receive autologous tumor cell-derived heat shock protein peptide vaccine intradermally weekly for 4 weeks. Patients receive subsequent vaccinations once every 2 weeks for at least 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with improving or stable disease or without recurrence continue on therapy for up to 1 year.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial of Active Specific Immunotherapy in Patients With Recurrent Soft Tissue Sarcoma Using Autologous Tumor-derived Heat Shock Protein-Peptide Complex (HSPPC-96)|
|Study Start Date :||November 1999|
|Primary Completion Date :||August 2001|
|Study Completion Date :||August 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005628
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Robert Maki, MD, PhD||Memorial Sloan Kettering Cancer Center|